XlentSkin

Product NDC: 71649-3776
Requested package NDC: 71649-3776-5
11-digit product format: 716493776
Labeler code: 71649
Product ID: 71649-3776_d82436ff-6bb2-aaff-e053-2995a90abe02
Type: HUMAN OTC DRUG
Nonproprietary name: Lanolin, Petrolatum
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Jiangsu Jiang Shi Biological Technology Co., Ltd.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2017-04-23
Marketing end: 0000-00-00
Substance: LANOLIN; PETROLATUM
Active strength: 16 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71649-3776	71649-3776-5	I	Inactivated by FDA		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71649-3776-5	2024-01-30	C162847	48780-1	9d75b9d0-b83c-f424-e053-dadaa90a57ce	XlentSkin
71649-3776-5	2022-02-18	C162847	48780-1	9d75b9d0-b83c-f424-e053-dadaa90a57ce	XlentSkin
71649-3776-5	2020-01-31	C162847	48780-1	9d75b9d0-b83c-f424-e053-dadaa90a57ce	XlentSkin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71649-3776-5	XlentSkin	30 g in 1 JAR	OINTMENT	30		3
71649-3776-5	XlentSkin	1 in 1 BOX	OINTMENT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71649-3776	XLENTSKIN (LANOLIN, PETROLATUM) OINTMENT [JIANGSU JIANG SHI BIOLOGICAL TECHNOLOGY CO., LTD.]	3	Legacy NDC, 2 package rows	20220219_55f3133c-da81-46f2-998a-8364def05ff8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7EV65EAW6H	LANOLIN	8006-54-0	LANOLIN
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1941523	lanolin 15.5 % / petrolatum 30 % Topical Ointment	PSN	55f3133c-da81-46f2-998a-8364def05ff8	3
1941523	lanolin 0.155 MG/MG / petrolatum 0.3 MG/MG Topical Ointment	SCD	55f3133c-da81-46f2-998a-8364def05ff8	3
1941523	lanolin 15.5 % / petrolatum 30 % Topical Ointment	SY	55f3133c-da81-46f2-998a-8364def05ff8	3
1941523	lanolin 15.5 GM per 100 GM / petrolatum 30 GM per 100 GM Topical Ointment	SY	55f3133c-da81-46f2-998a-8364def05ff8	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71649-3776-5	71649377605	1 JAR in 1 BOX (71649-3776-5) > 30 g in 1 JAR	1 jar	2017-04-23	0000-00-00	No	No	Current